Monday, September 15, 2014

Drug Shortages Happening So What's the Solution?

 

A recent trend in drug shortages resulting from manufacturers “experiencing product quality problems” and a lack of supply chain alternatives. Valerie Jensen, associate director of the FDA’s drug shortage program, announced the agency is temporarily leveraging foreign suppliers to alleviate supply constraint. Could this be one of the reasons why we have had so many problems with medication goof ups lately?
 
Am I the only one concerned about this? So if I am understanding the facts correctly we are in short supply of some meds-so we are going to trust other countries (possibly with some ties to unsavory political choices?) to supply us with them? Why are we then shipping so many medications to other countries again if it only causes us a shortage? Are we just setting ourselves up to be vulnerable to a terror attack through medications?
 
 
This is a scary reality they have so many shortages just check it out at : http://www.accessdata.fda.gov/scripts/drugshortages/
 
This is just a small list:
 
                                    
Generic Name or Active Ingredient Status
  Acetohydroxamic Acid (Lithostat) Tablets Currently in Shortage
  Acetylcysteine Inhalation Solution Resolved
  Amikacin Injection Currently in Shortage
  Aminocaproic Acid Injection Resolved
  Aminophylline Resolved
  Ammonium Chloride Injection Currently in Shortage
  Atracurium Besylate Resolved
  Atropine Sulfate Injection Currently in Shortage
  Barium Sulfate for Suspension Currently in Shortage
  Bumetanide Injection Resolved
  Bupivacaine Hydrochloride (Marcaine, Sensorcaine) Injection Currently in Shortage
  Buprenorphine Hydrochloride Injection Resolved
  Caffeine and Ergotamine Tartrate Tablets Resolved
  Caffeine Anhydrous (125mg/mL); Sodium Benzoate (125mg/mL) Injection12 Currently in Shortage
  Calcium Chloride Injection Resolved
  Calcium Gluconate Injection Currently in Shortage
  Cefazolin Injection Currently in Shortage
  Cefotetan Disodium Injection Currently in Shortage
  Chloramphenicol Sodium Succinate Injection Currently in Shortage
  Chromic Chloride Injection Resolved
  Cidofovir Injection Currently in Shortage
  Citric Acid; Gluconolactone; Magnesium Carbonate Solution (Renacidin) for Irrigation Resolved
  Clindamycin Phosphate (Cleocin) Injection Currently in Shortage
  Clonidine HCL Injection (Duraclon) Currently in Shortage
  Copper Injection Resolved
  Cyanocobalamin (Vitamin B12) Injection Currently in Shortage
  Daunorubicin Hydrochloride Solution for Injection Currently in Shortage
  Desmopressin Acetate (DDAVP) Injection Resolved
  Dexamethasone Sodium Phosphate Injection Currently in Shortage
  Dexmethylphenidate Hydrochloride (Focalin) Tablet Currently in Shortage
  Dextrose 5% Injection Bags Currently in Shortage
  Dextrose 50% Injection Resolved
  Dihydroergotamine Mesylate Injection Currently in Shortage
  Dipyridamole Injection Resolved
  Disopyramide Phosphate (Norpace) CR Currently in Shortage
  Disopyramide Phosphate (Norpace) CR Resolved
  Dobutamine Hydrochloride Injection Resolved
  Doxorubicin (Adriamycin) Lyophilized Powder Currently in Shortage
  Echothiophate Iodide (Phospholine Iodide) Ophthalmic Kit Resolved
  Ephedrine Sulfate Injection Currently in Shortage
  Epinephrine 1mg/mL (Preservative Free)13 Currently in Shortage
  Epinephrine Injection Currently in Shortage
  Erythrocin Lactobionate Lyophilized Powder for Injection Currently in Shortage
  Ethiodol (Ethiodized Oil) Ampules Currently in Shortage
  Etomidate (Amidate) Injection Resolved
  Famotidine Injection Currently in Shortage
  Fentanyl Citrate (Sublimaze) Injection Currently in Shortage
  Fluorescein Sodium Injection Currently in Shortage
  Furosemide Injection Resolved
  Haloperidol Lactate Injection Currently in Shortage
  Heparin Sodium Injection Currently in Shortage
  Hydromorphone Hydrochloride (Dilaudid) Injection Resolved
  Hydromorphone Hydrochloride (Dilaudid) Tablets Resolved
  Indigo Carmine Injection Currently in Shortage
  Intravenous Fat Emulsion Injection Resolved
  Irrigation Solutions Currently in Shortage
  Isoniazid; Rifampin Capsules Resolved
  Ketorolac Tromethamine Injection Resolved
  Leucovorin Calcium Lyophilized Powder for Injection Currently in Shortage
  Leuprolide Acetate Injection Currently in Shortage
  Levothyroxine Sodium (Levoxyl) Tablets Resolved
  Lidocaine Hydrochloride (Xylocaine) Injection Currently in Shortage
  Liotrix (Thyrolar) Tablets Currently in Shortage
  Lorazepam (Ativan) Injection Resolved
  Magnesium Sulfate Injection Currently in Shortage
  Mannitol (Osmitrol, Resectisol) Injection Resolved
  Mecasermin [rDNA origin] (Increlex) Injection Currently in Shortage
  Memantine Hydrochloride (Namenda) XR Capsules Currently in Shortage
  Methazolamide (Neptazane) Tablets Currently in Shortage
  Methazolamide (Neptazane) Tablets Resolved
  Methyldopate Hydrochloride Injection Currently in Shortage
  Methylin Chewable Tablets Currently in Shortage
  Methylphenidate Hydrochloride ER Capsules/Tablets14 Resolved
  Methylphenidate Hydrochloride Tablets Currently in Shortage
  Methylprednisolone Sodium Succinate Injection Resolved
  Metoclopramide (Reglan) Injection Resolved
  Morphine Sulfate (Astramorph PF, Duramorph, Infumorph) Injection (Preservative Free) Currently in Shortage
  Morphine Sulfate Injection Resolved
  Multi-Vitamin Infusion (Adult and Pediatric) Currently in Shortage
  Nalbuphine Hydrochloride (Nubain) Injection Currently in Shortage
  Neostigmine Methylsulfate Injection Resolved
  Nitroglycerin (Nitronal) Injection Currently in Shortage
  Nitroglycerin in 5% Dextrose Injection Currently in Shortage
  Ondansetron (Zofran) Injection Currently in Shortage
  Oseltamivir Phosphate (Tamiflu) Powder for Oral Suspension Resolved
  Pancuronium Bromide Injection Currently in Shortage
  Papaverine Hydrochloride Injection Currently in Shortage
  Pegvisomant (Somavert) Resolved
  Peritoneal Dialysis Solutions Currently in Shortage
  Phenylephrine Hydrochloride Ophthalmic Solution Currently in Shortage
  Phosphate (Glycophos) Injection Currently in Shortage
  Piperacillin and Tazobactam (Zosyn) Injection Currently in Shortage
  Potassium Acetate Injection, USP 2mEq/mL15 Resolved
  Potassium Chloride Injection Currently in Shortage
  Potassium Phosphate Injection Resolved
  Procainamide HCL Injection Resolved
  Prochlorperazine Injection Currently in Shortage
  Promethazine Injection Resolved
  Ranitidine Hydrochloride (Zantac) Injection Currently in Shortage
  Reserpine Tablets Currently in Shortage
  Rifampin for Injection Resolved
  Secretin Synthetic Human (ChiRhoStim) Injection Currently in Shortage
  Selenium Injection Currently in Shortage
  Sincalide (Kinevac) Lyophilized Powder for Injection Currently in Shortage
  Sodium Chloride 0.9% Injection Bags Currently in Shortage
  Sodium Chloride 23.4% Injection Currently in Shortage
  Sodium Phosphate Injection Currently in Shortage
  Succinylcholine (Anectine, Quelicin) Injection Currently in Shortage
  Sufentanil Citrate (Sufenta) Injection Currently in Shortage
  Sulfamethoxazole (SMX/TMP) (Bactrim) Injection16 Resolved
  Sulfamethoxazole and Trimethoprim (Bactrim) Oral Suspension Currently in Shortage
  Technetium tc99m Exametazime Injection (Ceretec Kit) Currently in Shortage
  Telavancin (Vibativ) Injection Resolved
  Tenecteplase (TNKase) Injection Resolved
  Tesamorelin (Egrifta) Injection Kit Currently in Shortage
  Tetracycline Capsules Resolved
  Thiotepa (Thioplex) for Injection Currently in Shortage
  Ticarcillin Disodium/Clavulanic Potassium (Timentin) Injection17 Resolved
  Tiopronin (Thiola) Currently in Shortage
  Tobramycin Solution for Injection Currently in Shortage
  Trace Elements Currently in Shortage
  Trimipramine Maleate (SURMONTIL) Capsules Currently in Shortage
  Tromethamine (Tham) Injection Resolved
  Verapamil Hydrochloride Injection, USP Currently in Shortage
  Vitamin A Palmitate (Aquasol A) Injection Resolved
  Zinc Injection Currently in Shortage
 

Saturday, September 13, 2014

Planned Parenthood Fraud






In 2011, Susan Thayer filed an action on behalf of the United States and the State of Iowa against Planned Parenthood of the Heartland, Inc. It alleges that Planned Parenthood violated the federal False Claims Act and its Iowa state analog. Thayer's complaint asserted that her former employer submitted false or fraudulent claims for Medicaid reimbursement by seeking payment for services that were either not reimbursable at all or not in the amounts sought. Thayer claimed her knowledge of Planned Parenthood's billing practices was gained during her years of employment as a manager of two of the organization's clinics in Iowa.

Planned Parenthood moved to dismiss the complaint on the grounds that Thayer failed to allege fraud with particularity as required by Federal Rule of Civil Procedure 9(b). The United States District Court for the Southern District of Iowa granted Planned Parenthood's motion, ruling that Thayer did not satisfy Rule 9(b) because she did not plead any "representative examples" of the alleged fraudulent conduct. Thayer appealed.

On August 29, 2014, the United States Court of Appeals for the Eight Circuit largely reversed the district court's decision, holding that an FCA plaintiff who pleads details of the defendant's billing practices and personal knowledge of the defendant's submission of false claims does not need to provide representative examples of the false claims in order to satisfy Rule 9(b).

Reimbursements at higher rates than permitted and the plaintiff alleged that every claim submitted over a sixteen-year period was fraudulent, but did not identify the details of any of the allegedly false claims. The Court dismissed Joshi's complaint for failing to plead fraud with particularity under Rule 9(b), holding that because Joshi was a doctor rather than a member of the hospital's billing department, he could not plead that false claims were actually submitted. Therefore, in order to establish a factual basis for the allegedly systematic practice of presenting false claims, the Court held that he would have to provide representative examples.

Declining merely to employ the test it adopted in Joshi, the Court observed that Thayer's allegations were based on personal knowledge of the billing practices at issue, suggesting greater reliability than the allegations in Joshi's complaint. In these circumstances, the Court held, the complaint could satisfy Rule 9(b) by identifying particular details of the alleged scheme, without the necessity of providing specific examples. Applying this standard to Thayer's allegations, the Court reinstated the majority of her claims, effectively reversing its own earlier decision in Joshi.

Coming soon after the Third Circuit's June 2014 ruling, the Thayer decision tips the balance, suggesting that the federal courts may coalesce around a more flexible standard for FCA complaints, rather than a strict requirement for representative examples. Such a development should be welcomed by whistleblowers who uncover FCA violations, because they are often unable to provide actual billing records.

Antibiotics Being Overused-Deadly Combinations



Hospitals continue to overuse antibiotics despite warnings that pervasive use can lead to drug resistance and cause billions of dollars in excess healthcare costs, according to a retrospective analysis of 505 hospital members of the Premier health alliance.

Inappropriate use of antibiotic combinations was noted in nearly 80% of the facilities analyzed, and overuse of the most common therapies led to an excess spending of nearly $13 million.

Healthcare organizations are encouraged to develop a list of antibiotic “never combinations”—those for which there is no evidence to support continued use—and create an alert system to flag when the drugs are ordered.

Combating overuse of antibiotics remains a major public health concern. Their use is the most important factor leading to antibiotic resistance around the world, according to a Centers for Disease Control and Prevention alert issued last year.

The federal agency estimates at least 2 million people in the U.S. each year become infected with drug-resistant bacteria and at least 23,000 die as a direct result. Over the past few years, the CDC, Food and Drug Administration and several medical specialty organizations through the Choosing Wisely campaign have issued warnings or recommendations to encourage safe use of antibiotics.

Using administrative data from Premier, the company’s researchers and the CDC’s associate director for Healthcare Associated Infection Prevention Programs, Dr. Arjun Srinivasan investigated the incidence and economic impact of potentially overused antibiotics used by hospitals between Jan. 1, 2008, and Dec. 31, 2011. Of the 505 hospitals included, researchers found evidence of “potentially inappropriate, redundant antimicrobial coverage” for 23 antimicrobial combinations in 78%, or 394 of the hospitals. This accounted for 32,507 individual cases of patients who received at least two consecutive days of one or more of the antibiotic combinations.